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Case Studies

Conducting biosimilar clinical trials

Case Study: Nucleus Network

Nucleus Network is a dedicated Phase I clinical trials organisation located in Melbourne, Australia. It undertakes approximately 50 clinical trials a year, including up to 15 first-in-human studies, at its dedicated Phase I unit located within the Alfred Medical Research Education Precinct at Melbourne’s Alfred Hospital. The unit contains 50 beds and incorporates state-of-the-art subject monitoring to ensure volunteer safety and comfort. Nucleus Network is experienced in delivering adaptive clinical trial protocol designs, and has good access to patient populations through co-location with one of the state’s major tertiary teaching hospitals.

Nucleus Network’s international client base is attracted to Australia’s streamlined regulatory framework, and fast approval timelines for clinical trials. Typical timeframes for a Phase I clinical trial, from submission of Protocol and Investigators Brochure, to clinical trial approval, is 4 to 5 weeks. This pathway has proven to be an attractive and successful model for clients, who have been able to enter Phase I clinical trials sooner than originally forecast, and with quality data that is acceptable to the US Food and Drug Administration (FDA) and European Medicines Evaluation Agency (EMEA). Nucleus Network has a number of preferred provider relationships with both pharmaceutical and biotechnology companies.

Nucleus Network offers a full suite of early phase clinical studies, including first-in-human; proof of concept; pharmacokinetic and pharmacodynamic; thorough QTC; bioequivalence; drug/ food interaction studies, as well as specialty studies incorporating a range of pharmacodynamic markers such as Elispot, Flow Cytometry, Cytokine analysis and allergen challenges.

In 2014 Nucleus conducted a biosimilar clinical trial for a large biotechnology company. Incorporating an ethnopharmacology component, Nucleus conducted the trial with a cohort of 30 healthy Japanese subjects. After successful completion of the trial, the same sponsor has now awarded a second biosimilar study to Nucleus.

Health and medical research in Victoria

Case Study: Doherty Institute

The Melbourne-based world-class Doherty Institute (also known as Peter Doherty Institute) for Infection and Immunity is a partnership between the University of Melbourne and Melbourne Health.

It is named after the esteemed Nobel Laureate (1996) and Laureate Professor at the University of Melbourne, Professor Peter Doherty, who is also the Institute’s Patron.

Leading Melbourne scientist and Melbournian of the year in 2014, Professor Sharon Lewin is Director of the Doherty Institute. In the video, she talks about health and medical research in Victoria. About 70% of staff at the Institute are university-based and over 700 staff work on all aspects of infectious diseases and how to tackle and prevent and ultimately cure many of the most serious infectious diseases we face today.

“The Government helps in a whole range of ways, of course, infrastructure, so many of the buildings and hardware that we need to do the work is provided by government. The Peter Doherty Institute is a brand new, 11 storey building in the heart of Melbourne. It cost 210 million dollars to build and that was through contributions from the State Government of Victoria, the Commonwealth Government and the University of Melbourne.” says Prof Lewin.

Prof Lewin is an infectious diseases physician and basic scientist, and an international expert on all aspects of HIV disease and pathogenesis. She is the inaugural director of the Doherty Institute for Infection and Immunity at the University of Melbourne; consultant physician, Alfred Hospital, Melbourne, Australia; and an Australian National Health and Medical Research Council (NHMRC) Practitioner Fellow. She was previously Head, Department of Infectious Diseases, The Alfred Hospital and Monash University (2003 – 2014) and Co-head, Centre for Biomedical Research, Burnet Institute (2010-2014), Melbourne, Australia.

She leads a large multi-disciplinary research team that focuses on understanding why HIV persists on treatment, developing clinical trials aimed at ultimately finding a cure for HIV infection and understanding HIV-related immune reconstitution and how HIV interacts with other viruses such as hepatitis B virus (HBV).

Manufacturing active pharmaceutical ingredients for clinical trials

Case Study: IDT

Australia Successful pharmaceutical companies rely on new products to keep them ahead of the competition, but developing and bringing them to market on-time and onbudget requires knowledge, competence and a proven track record. IDT helps fast-track products from research and development, through to clinical trials. With over 35 years’ experience, IDT has developed more than 115 products for customers including 9 of the top 10 pharmaceutical companies worldwide.

IDT specialise in developing and manufacturing complex, highly potent drugs, beta-lactam antibiotics and cytotoxic products at their Melbourne manufacturing campus. In addition, IDT CMAX is a 50-bed clinical trial unit currently located at the Royal Adelaide Hospital, South Australia.

IDT CMAX specialises in first-in-human studies, and has conducted over 75 to date. In 2016 IDT CMAX will relocate to purpose-built premises adjacent to the new South Australian Health and Biomedical Precinct. This will be the largest health precinct in the southern hemisphere, and provide the foundation for a cluster of organisations to deliver world-leading research and clinical service delivery. Centrally located, with easy access to public transport for study participants and customers, the new facility will continue to offer 50 beds, allowing flexibility for study scheduling and fast study startup times.

Most recently IDT helped a United States biotechnology company efficiently conduct a Phase I trial of their product. They chose IDT to conduct active pharmaceutical ingredient (API), finished dosage form, and early proof of concept clinical work. IDT helped to manufacture the API and formulate the drug product, which was then put into Phase I clinical trials at IDT CMAX. This biotechnology company was able to access the R&D tax incentive tax credit, and quickly start the trial process using the CTN scheme, without needing to secure a United States Investigational New Drug (IND) filing, saving both time and money.